ADVM Adverum Biotechnologies Inc.

2.24
-0.01  -0%
Previous Close 2.25
Open 2.29
52 Week Low 2.065
52 Week High 14.79
Market Cap $219,801,940
Shares 98,125,866
Float 92,400,327
Enterprise Value $-14,495,061
Volume 243,361
Av. Daily Volume 1,979,452
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
ADVM-022 (OPTIC)
Wet age-related macular degeneration (Wet-AMD)
Phase 1
Phase 1
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
ADVM-022 - INFINITY
Diabetic macular edema
Phase 2
Phase 2
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Latest News

  1. REDWOOD CITY, Calif., Aug. 23, 2021 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced that Jim Wang, Ph.D., has been appointed senior vice president, head of regulatory affairs. Reporting directly to Laurent Fischer, M.D., Adverum's president and chief executive officer, Dr. Wang will lead regulatory strategies and execution for the company's product pipeline. He brings more than 17 years of global regulatory experience, including a decade in gene therapy that includes the submission and approval for LUXTURNA®, the first gene therapy targeting a genetic disease that received regulatory approval in both the U.S. and…

    REDWOOD CITY, Calif., Aug. 23, 2021 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced that Jim Wang, Ph.D., has been appointed senior vice president, head of regulatory affairs. Reporting directly to Laurent Fischer, M.D., Adverum's president and chief executive officer, Dr. Wang will lead regulatory strategies and execution for the company's product pipeline. He brings more than 17 years of global regulatory experience, including a decade in gene therapy that includes the submission and approval for LUXTURNA®, the first gene therapy targeting a genetic disease that received regulatory approval in both the U.S. and EU.  

    "Jim brings expansive knowledge, expertise, and insight into global regulatory strategy gained at some of the most well-respected companies in our industry," said Laurent Fischer, M.D., president and chief executive officer at Adverum Biotechnologies. "From his early background as a bench scientist to leading regulatory approvals globally for numerous prescription drugs, including the U.S. and EU approvals of the first ocular gene therapy LUXTURNA®, Jim's leadership will be instrumental in moving forward with the best possible path for ADVM-022 in wet AMD and advancing our pipeline programs."

    "Laurent and the team share my passion for gene therapy research and development and have the scientific and ocular disease expertise to deliver potential transformative gene therapy treatments for patients," said Dr. Wang. "Every drug has a unique benefit and risk profile, and I am inspired to work with this team on the regulatory strategy and path for ADVM-022 in wet AMD as well as for our novel pipeline gene therapy programs advancing toward the clinic."

    Dr. Wang joins Adverum from PTC Therapeutics, where he served as vice president, global head of regulatory strategy, leading the planning and execution of worldwide regulatory activities across all therapeutic areas focusing on rare disease. He also provided oversight to a cross-functional team for the marketing application of the gene therapy product eladocagene exuparvovec. Previously, he worked with Spark Therapeutics, serving as vice president, head of regulatory affairs strategy. At Spark, he led the Agency interaction and BLA/MAA submission and approval for LUXTURNA®, a gene therapy to treat children and adult patients with an inherited form of vision loss. In prior positions, he was executive director, global regulatory affairs at Shire Pharmaceutical (now Takeda); senior director at Novo Nordisk responsible for global health authority interaction and marketing applications for Saxenda®; and director of CV, diabetes, and obesity at Bristol-Myers Squibb. Earlier, at Sanofi-Aventis, Dr. Wang served as associate director of CV, thrombosis, and CNS, and led the global regulatory efforts for a late-stage gene therapy product targeting peripheral artery disease. He began his career at Pfizer (formerly Wyeth Pharmaceuticals) as a scientist working in drug safety and metabolism.

    Dr. Wang earned his Ph.D. in chemistry from the University of Illinois at Urbana-Champaign and an MBA from Pennsylvania State University.

    Inducement Grants

    On August 23, 2021, the company granted Dr. Wang a stock option to purchase 375,000 shares of Adverum's common stock pursuant to the inducement grant exception under Nasdaq Rule 5635(c)(4), as an inducement that is material to his entering into employment with Adverum. The option has a per share exercise price equal to the closing sales price of Adverum's common stock on the Nasdaq Stock Market on the grant date, and will vest over four years, subject to his continued service with Adverum.

    On August 23, 2021, the company granted Karina Nip, CPA, vice president, controller a stock option to purchase 100,000 shares of Adverum's common stock pursuant to the inducement grant exception under Nasdaq Rule 5635(c)(4), as an inducement that is material to the employee entering into employment with Adverum. The option has a per share exercise price equal to the closing sales price of Adverum's common stock on the Nasdaq Stock Market on the grant date, and will vest over four years, subject to her continued service with Adverum.

    About Adverum Biotechnologies 

    Adverum Biotechnologies (NASDAQ:ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is evaluating its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with wet age-related macular degeneration. For more information, please visit www.adverum.com.



    Investor Inquiries
    Amy Figueroa, CFA
    Vice President, Investor Relations and Corporate Communications
    Adverum
    T: 650-649-1257
    
    Media Inquiries
    Andrea Cohen
    Sam Brown Inc. 
    T: 917-209-7163

    Primary Logo

    View Full Article Hide Full Article
  2. REDWOOD CITY, Calif., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today reported financial results for the second quarter ended June 30, 2021.

    "Adverum has an experienced team and is well capitalized to execute our current plans to prioritize the development of ADVM-022 in wet age-related macular degeneration," said Laurent Fischer, M.D., president and chief executive officer at Adverum Biotechnologies. "Based on our current focus and timelines, we are able to extend our cash runway into 2024. The long-term data from OPTIC in patients with wet AMD show the potential for the low dose of ADVM-022 to offer durable…

    REDWOOD CITY, Calif., Aug. 05, 2021 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today reported financial results for the second quarter ended June 30, 2021.

    "Adverum has an experienced team and is well capitalized to execute our current plans to prioritize the development of ADVM-022 in wet age-related macular degeneration," said Laurent Fischer, M.D., president and chief executive officer at Adverum Biotechnologies. "Based on our current focus and timelines, we are able to extend our cash runway into 2024. The long-term data from OPTIC in patients with wet AMD show the potential for the low dose of ADVM-022 to offer durable, disease-modifying treatment following a single, in-office intravitreal injection. The current standard of care for wet AMD requires frequent anti-VEGF injections in the eye, which are a burden for patients, caregivers, and healthcare systems and make access challenging for many patients. Our team is committed to patient safety and moving forward with the best possible path to deliver ADVM-022 to patients with wet AMD, and potentially delivering a durable new treatment alternative to frequent injections for these patients in the future."

    Recent Developments

    • At the Association for Research in Vision and Ophthalmology (ARVO) meeting in May, long-term OPTIC clinical data (n=30, March 10, 2021 data cut) were presented demonstrating the potential of ADVM-022 to greatly reduce the anti-VEGF intravitreal (IVT) injection burden for patients with wet AMD. Data demonstrated long-term durability and maintained efficacy with a majority of patients free of supplemental injection following a single, in-office IVT injection of ADVM-022 in difficult-to-treat patients with wet AMD.
    • Adverum is no longer planning to develop ADVM-022 for diabetic macular edema (DME) or at the high dose (6 x 10^11 vg/eye). No similar clinically-relevant events like the dose-limiting toxicity (DLT) at the high dose in DME patients have been observed to date in patients with wet AMD, and patients in OPTIC have reached a follow-up period of between 1 and 2.5 years post treatment.
    • Adverum is in active discussions to sublease the company's 174,000-square-foot Good Manufacturing Practices (GMP) commercial manufacturing facility in Research Triangle Park, NC. Adverum will leverage its contract manufacturing organization (CMO) partners for ongoing supply of ADVM-022.

    Anticipated Milestones for ADVM-022:

    • Plan to present long-term OPTIC data in wet AMD in 2H21, including 52-week data from Cohort 4 (high dose of 6 x 10^11 vg/eye with steroid eye drop prophylaxis, n=9), at a medical conference
    • Plan to present INFINITY data in DME in 2H21 at a medical conference
    • Plan to complete data analysis by YE21 to develop a protocol and seek investigator and regulatory feedback on a Phase 2 clinical trial in wet AMD to evaluate low doses (2 x 10^11 vg/eye and lower) of ADVM-022 and alternative prophylactic regimens

    Financial Results for the Three Months Ended June 30, 2021

    • Cash, cash equivalents and short-term investments were $363.8 million as of June 30, 2021, compared to $404.0 million as of March 31, 2021. Adverum expects this quarter-end cash position to fund operations into 2024, 18 months beyond prior guidance of mid-2022. Adverum's cash runway extension is based on current development and manufacturing plans for ADVM-022, including conducting a Phase 2 trial instead of two Phase 3 trials in wet AMD, not pursuing future development in DME, and continuing to utilize contract CMO partners in lieu of establishing a GMP commercial manufacturing facility.
    • Research and development expenses were $22.6 million for the three months ended June 30, 2021, compared to $19.2 million for the same period in 2020. Research and development expenses increased primarily due to higher personnel-associated costs, rent expense, clinical trial expenses, consultant and contractor fees, and laboratory costs, partially offset by decreased material production costs. Stock-based compensation expense included in research and development expenses was $2.6 million for the second quarter of 2021, compared to $1.7 million for the same period in 2020.
    • General and administrative expenses were $21.9 million for the three months ended June 30, 2021, compared to $10.6 million for the same period in 2020. General and administrative expenses increased primarily due to higher professional services costs, including proxy related fees, personnel-associated costs, and rent for new leases commenced in the second quarter of 2021. Stock-based compensation expense included in general and administrative expenses was $5.7 million for the second quarter of 2021, compared to $3.1 million for the same period in 2020.
    • Net loss was $44.3 million, or $0.45 per basic and diluted share, for the three months ended June 30, 2021, compared to $29.2 million, or $0.36 per basic and diluted share, for the same period in 2020.

    About Adverum Biotechnologies

    Adverum Biotechnologies (NASDAQ:ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is evaluating its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with wet age-related macular degeneration. For more information, please visit www.adverum.com.

    Forward-looking Statements

    Statements contained in this press release regarding the events or results that may occur in the future are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include but are not limited to statements regarding the expected current cash runway into 2024, and the statements under the caption "Anticipated Milestones for ADVM-022." Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include risks inherent to, without limitation: Adverum's novel technology, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval; the results of early clinical trials not always being predictive of future results; and the potential for Adverum's recent announcement of a dose-limiting toxicity at the high dose in DME patients in our INFINITY trial, and any future complications or side effects in connection with use of ADVM-022, to delay or prevent regulatory advancement or approval for ADVM-022. Risks and uncertainties facing Adverum are described more fully in Adverum's Annual Report on Form 10-K for the year ended December 31, 2020, Adverum's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, and any subsequent filings with the SEC, especially under the heading "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



         
    Adverum Biotechnologies, Inc.
    Consolidated Balance Sheets
    (In thousands)
         
      June 30 December 31
       2021   2020 
      (Unaudited)  (1)
    Assets     
    Current assets:    
    Cash and cash equivalents $47,299  $62,424 
    Short-term investments  316,544   367,305 
    Lease incentive receivables  16,196   - 
    Prepaid expenses and other current assets 6,233   4,709 
    Total current assets  386,272   434,438 
    Property and equipment, net  31,589   27,725 
    Operating lease right-of-use asset  101,876   19,376 
    Restricted cash  6,282   999 
    Deposit and other long-term assets  128   29 
    Total assets $526,147  $482,567 
         
    Liabilities and stockholders' equity     
    Current liabilities:    
    Accounts payable  2,259   2,810 
    Lease liability, current portion  4,185   4,473 
    Accrued expenses and other current liabilities  14,086   13,588 
    Total current liabilities  20,530   20,871 
    Lease liability, net of current portion  125,361   26,235 
    Other noncurrent liabilities  1,114   1,114 
    Total liabilities  147,005   48,220 
    Stockholders' equity:    
    Common stock  10   10 
    Additional paid-in capital  954,854   937,134 
    Accumulated other comprehensive loss  (417)  (261)
    Accumulated deficit  (575,305)  (502,536)
    Total stockholders' equity  379,142   434,347 
    Total liabilities and stockholders' equity$526,147  $482,567 
         

    (1) Derived from Adverum's annual audited consolidated financial statements

    Adverum Biotechnologies, Inc.
    Consolidated Statements of Operations
    (In thousands except per share data)
    (Unaudited)
      Three months ended June 30, Six months ended June 30,
       2021   2020   2021   2020 
             
    License revenue $-  $-  $7,500  $- 
             
    Operating expenses:        
    Research and development  22,608   19,177   42,588   33,928 
    General and administrative  21,930   10,598   38,093   19,638 
    Total operating expenses  44,538   29,775   80,681   53,566 
    Operating loss  (44,538)  (29,775)  (73,181)  (53,566)
    Other income, net  205   575   412   1,460 
    Net loss  (44,333)  (29,200)  (72,769)  (52,106)
    Net loss per share — basic and diluted $(0.45) $(0.36) $(0.74) $(0.68)
    Weighted-average common shares outstanding - basic and diluted  98,018   80,229   97,885   77,010 
             





    Investor Inquiries
    Amy Figueroa, CFA
    Vice President, Investor Relations and Corporate Communications
    Adverum
    E: afigueroa@adverum.com
    T: 650- 649-1257
    
    Media Inquiries
    Andrea Cohen
    Sam Brown Inc.
    E: andreacohen@sambrown.com
    T: 917-209-7163

    Primary Logo

    View Full Article Hide Full Article
  3. -- Based on latest analyses, company is revising ADVM-022 development plan to focus on wet AMD and low doses (2 x 10^11 vg/eye and lower); no longer planning development for DME --

    -- Company to host conference call and webcast today at 1:30 pm PT / 4:30 pm ET --

    REDWOOD CITY, Calif., July 22, 2021 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today provided an update on the ADVM-022 development program following a thorough review of data available from the INFINITY clinical trial in patients with diabetic macular edema (DME) and the OPTIC clinical trial in patients with wet age-related macular degeneration (wet AMD). The data…

    -- Based on latest analyses, company is revising ADVM-022 development plan to focus on wet AMD and low doses (2 x 10^11 vg/eye and lower); no longer planning development for DME --

    -- Company to host conference call and webcast today at 1:30 pm PT / 4:30 pm ET --

    REDWOOD CITY, Calif., July 22, 2021 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today provided an update on the ADVM-022 development program following a thorough review of data available from the INFINITY clinical trial in patients with diabetic macular edema (DME) and the OPTIC clinical trial in patients with wet age-related macular degeneration (wet AMD). The data from the studies show marked differences in the safety profile between the two patient populations and between the low (2 x 10^11 vg/eye) versus high (6 x 10^11 vg/eye) doses. Adverum no longer plans future development for DME after a dose-limiting toxicity (DLT) not seen before in ocular gene therapy or anti-VEGF treatment has been observed at the high dose (6 x 10^11 vg/eye) in patients with DME. The company is planning to evaluate ADVM-022, a single intravitreal (IVT) injection gene therapy, at low doses (2 x 10^11 vg/eye and lower) and with alternative prophylactic regimens in a future Phase 2 clinical trial in wet AMD.

    Wet AMD and DME have different pathophysiological causes with different risk factors. While the root cause of the DLT is not yet known, diabetic patients with DME typically have multiple underlying comorbidities, such as severe vascular disease, which can contribute to inflammatory factors that may induce an increase in vascular permeability and disrupt the blood-ocular barrier in DME patients.i

    As disclosed in late April 2021, Adverum immediately unmasked INFINITY and began closely monitoring all patients treated to date with ADVM-022 following a Suspected Unexpected Serious Adverse Reaction (SUSAR) of hypotony in the treated eye of a patient with DME who received a single high dose of ADVM-022. Additional patients in INFINITY treated with a single high dose of ADVM-022 have, despite close monitoring and aggressive treatment, experienced adverse events that have included rapid, clinically-relevant decreases in intraocular pressure refractory to steroids and requiring subsequent additional treatment. These events occurred 16-36 weeks after treatment with the high dose. No similar clinically-relevant events have been observed to date in DME patients in INFINITY treated with the low dose or to date in any wet AMD patients in OPTIC treated at either the high or low dose. The company is closely managing patient care working with the data monitoring committee (DMC), its scientific advisory board (SAB), leading retina specialists, and investigators. All clinical trial sites and the U.S. Food and Drug Administration (FDA) have been advised of these cases.

    "Our primary focus remains patient safety," said Laurent Fischer, M.D., president and chief executive officer at Adverum Biotechnologies. "We deeply appreciate the continued expertise shared by the DMC, the SAB, retina specialists, and investigators to guide best patient care decisions. Gene therapy is a new and very promising, yet challenging field, as we work to develop durable treatments for patients. Our team is grateful for all of the patients and investigators participating in our clinical studies for their critical roles as we strive to shift the treatment paradigm through developing a one-time intravitreal gene therapy for patients."

    Dr. Fischer continued, "Based on an ongoing, thorough review of the clinical and non-clinical data for ADVM-022, we are planning future development for wet AMD and we no longer plan to pursue DME. The data show marked differences for ADVM-022 in patients with wet AMD versus DME. Our fully dedicated team and expert advisors are working relentlessly to better understand the root cause of the events experienced by certain high-dose patients in INFINITY and potential risk factors in these patients with DME. Following completion of our analysis and discussions with advisors and regulators, we are planning a Phase 2 clinical trial in wet AMD patients to explore additional low doses with alternative prophylactic regimens to support the best possible path for delivering ADVM-022 safely to patients."

    "Working collectively, the DMC, SAB, investigators, leading specialists, and Adverum have taken swift action to assess and provide the best care to patients," said Szilárd Kiss, M.D., Associate Professor in Ophthalmology and member of Adverum's Scientific Advisory Board. "In unmasking INFINITY, the company has taken the right steps immediately to share findings real-time and ensure investigators can closely monitor patients and manage patient safety. Dose finding has been a challenge for the field of gene therapy, and while AAV remains a very safe delivery system, we should expect as with any biologic product that unexpected dose-limiting toxicities may be encountered. It is important to learn from the data generated by this field to bring new treatments with durable efficacy and well-managed safety to patients."

    Long-term data from the OPTIC trial (n=30) of ADVM-022 for wet AMD have demonstrated long-term durability and maintained efficacy following a single, in-office IVT injection. Safety and efficacy data presented at the Association for Research in Vision and Ophthalmology (ARVO) in April 2021 showed 60% of patients were injection-free beyond one year and patients had an 85% reduction in annualized injection frequency following a single low dose (n=15). The company plans to present additional long-term data at a medical conference in the fall of 2021.

    The company plans to report financial results for the second quarter 2021 on August 5, 2021 after market close and remains well capitalized to execute on its priorities.

    Recent Developments

    • Adverum no longer plans future development of ADVM-022 for DME.
    • Data from the ADVM-022 program show marked differences in the safety profile between the AMD and DME patient populations and between the low (2 x 10^11 vg/eye) versus high (6 x 10^11 vg/eye) dose. Some patients in INFINITY treated with a single high dose of ADVM-022 have experienced adverse events, despite close monitoring and aggressive treatment, that have included rapid, clinically-relevant decreases in intraocular pressure refractory to steroids and requiring subsequent additional treatment.
      • In OPTIC (n=30) in wet AMD, Adverum has requested that all patients be evaluated in person by investigators to receive additional monitoring. Their clinical data have been reviewed following the INFINITY SUSAR. No similar clinically-relevant events have been observed to date post treatment with either the high or low dose in OPTIC. Patients in OPTIC have reached a follow up period of between 52 weeks and 2.5 years post treatment.
      • In INFINITY (n=34) in DME, all patients are being monitored closely. No similar clinically-relevant events have been observed to date in patients treated with the low dose (n=13). For patients treated with the high dose (n=12), aggressive immunomodulatory regimens are being recommended to mitigate potential risk. To date, five of these twelve patients treated with the high dose have experienced similar clinically-relevant events. All of these patients had a history of severe vascular disease, and all events occurred 16-36 weeks post treatment. Three of these patients to date have required surgery on the treated eye. The remaining high-dose patients are being assessed and monitored closely by leading experts. All patients in INFINITY are out a minimum of 24 weeks post treatment.
      • As previously reported, in April 2021 a SUSAR of hypotony occurred in a patient in the INFINITY trial in DME 30 weeks after treatment with a single IVT injection of high dose ADVM-022. The patient has been evaluated and treated by leading experts and, at present, some ocular pressure and some vision have been restored in the patient's treated eye.
      • Adverum continues to assess and monitor all patients treated with ADVM-022 and to conduct a thorough review of all patient data from INFINITY and OPTIC (n=64) and preclinical data. Working closely with the DMC, SAB, investigators, and leading retina specialists, Adverum continues to investigate the root cause, using rigorous analyses and state-of-the-art technologies to make data-driven decisions on prophylactic regimens and treatment.

    Anticipated Milestones for ADVM-022:

    • Plan to present long-term OPTIC data in wet AMD in 2H21, including 52-week data from Cohort 4 (high dose of 6 x 10^11 vg/eye with steroid eye drop prophylaxis, n=9), at a medical conference
    • Plan to present INFINITY data in DME in 2H21 at a medical conference
    • Plan to complete data analysis by YE21 to develop a protocol and seek investigator and regulatory feedback on a Phase 2 clinical trial in wet AMD to evaluate low doses (2 x 10^11 vg/eye and lower) of ADVM-022 and alternative prophylactic regimens

    Conference Call Today

    Adverum will host a conference call and webcast today at 1:30 pm PT / 4:30 pm ET to provide an update on the ADVM-022 development program. The live webcast will be accessible under Events and Presentations in the Investors section of the company's website. To participate in the conference call, dial 1-877-705-6003 (domestic) or 1-201-493-6725 (international) and reference Adverum conference call and webcast. Due to high call volume, it is recommended call participants dial in 15 minutes in advance. The archived audio webcast will be available on the Adverum website following the call and will be available for 30 days.

    About the OPTIC Trial of ADVM-022 in Wet AMD

    This multi-center, open-label, Phase 1, dose-ranging trial was designed to assess the safety and tolerability of a single intravitreal (IVT) administration of ADVM-022 in patients with wet AMD who are responsive to anti-vascular endothelial growth factor (VEGF) treatment. Wet AMD is a leading cause of vision loss in patients over 60 years of age, with a prevalence of approximately 1.2 million individuals in the U.S. and 3 million worldwide.

    In Cohort 1 (n=6) and Cohort 4 (n=9), patients received a high dose (6 x 10^11 vg/eye) and in Cohort 2 (n=6) and Cohort 3 (n=9), patients received a low dose (2 x 10^11 vg/eye) of ADVM-022. Patients in Cohorts 3 and 4 received six weeks of prophylactic steroid eye drops rather than 13 days of prophylactic oral steroids which were used in Cohorts 1 and 2. The primary endpoint of the trial is the safety and tolerability of ADVM-022 after a single IVT administration. Secondary endpoints include changes in best-corrected visual acuity (BCVA), measurement of central retinal thickness (CRT) and the need for supplemental anti-VEGF injections. Each patient enrolled is being followed for a total of two years with the option to enroll in an extension study for an additional 3 years. For additional information about the OPTIC trial, please visit https://clinicaltrials.gov/ct2/show/NCT03748784 and for information about the long-term extension study, please visit https://clinicaltrials.gov/ct2/show/NCT04645212.

    About the INFINITY Trial of ADVM-022 in DME

    INFINITY is a Phase 2, multi-center, randomized, double-masked, active comparator-controlled trial designed to assess a single intravitreal (IVT) injection of ADVM-022 in patients with diabetic macular edema (DME), the most common cause of vision loss in patients with diabetic retinopathy (DR).

    The INFINITY trial enrolled 36 patients and was designed to demonstrate superior control of disease activity following a single IVT injection of ADVM-022 compared to a single aflibercept injection, as measured by time to worsening of DME disease activity. Participants in this double-masked trial were randomized to one of three arms for their study eye treatment: Arm 1 received high dose (6 x 10^11 vg/eye) of ADVM-022, Arm 2 received low dose (2 x 10^11 vg/eye) of ADVM-022, and Arm 3 received aflibercept at a dose of 2 mg. Patients assigned to receive ADVM-022 were further randomized to receive either a preceding aflibercept or sham ocular injection. Additional objectives include assessments of treatment burden, visual acuity, retinal anatomy, and safety outcomes. For additional information about the INFINITY trial, please visit www.clinicaltrials.gov using Identifier NCT#04418427. 

    About ADVM-022 Gene Therapy

    ADVM-022 utilizes Adverum's propriety vector capsid, AAV.7m8, carrying an optimized aflibercept coding sequence under the control of a proprietary expression cassette. ADVM-022 is administered as a one-time intravitreal (IVT) injection, designed to deliver long-term efficacy, reduce the burden of frequent anti-VEGF injections, and improve real-world vision outcomes for patients with wet age-related macular degeneration (wet AMD). In recognition of the need for new treatment options for wet AMD, the U.S. Food and Drug Administration granted Fast Track designation to ADVM-022 for the treatment of wet AMD.

    About Adverum Biotechnologies

    Adverum Biotechnologies (NASDAQ:ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is evaluating its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with wet age-related macular degeneration. For more information, please visit www.adverum.com.

    Forward-looking Statements

    Statements contained in this press release regarding the events or results that may occur in the future are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include but are not limited to statements: in Dr. Fischer's quote regarding Adverum planning future development for wet AMD and no longer planning to pursue DME; that Adverum is planning a Phase 2 clinical trial in wet AMD patients to explore additional low doses with alternative prophylactic regimens to support the best possible path for delivering ADVM-022 safely to patients; and under the caption "Anticipated Milestones for ADVM-022." Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include risks inherent to, without limitation: Adverum's novel technology, which makes it difficult to predict the time and cost of product candidate development and obtaining regulatory approval; the results of early clinical trials not always being predictive of future results; and the potential for additional SUSARs or adverse events, or any future complications or side effects in connection with use of ADVM-022 to delay or prevent regulatory advancement or approval for ADVM-022. Risks and uncertainties facing Adverum are described more fully in Adverum's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, and any subsequent filings with the SEC, especially under the heading "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

    ______________________

    i Noma H, Mimura T, Yasuda K, Shimura M: Role of Inflammation in Diabetic Macular Edema. Ophthalmologica 2014;232:127-135. doi: 10.1159/000364955



    Investor Inquiries
    Amy Figueroa, CFA
    Vice President, Investor Relations and Corporate Communications
    Adverum
    E: afigueroa@adverum.com
    T: 650- 649-1257
    
    Media Inquiries
    Chantal Allan
    Sam Brown Inc.
    E: chantalallan@sambrown.com 
    T: 805-242-3080

    Primary Logo

    View Full Article Hide Full Article
  4. REDWOOD CITY, Calif., July 01, 2021 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced the appointment of Jon Williams, Ph.D., as vice president, clinical affairs, effective immediately. Dr. Williams will provide scientific and technical expertise and leadership across Adverum's clinical development program for ADVM-022, reporting to Julie Clark, M.D., chief medical officer.

    "Jon is a dynamic scientist and prolific published researcher, bringing 25 years of experience in clinical and preclinical drug and medical device development and regulatory strategies to this new position at Adverum," said Julie Clark, M.D.,

    REDWOOD CITY, Calif., July 01, 2021 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced the appointment of Jon Williams, Ph.D., as vice president, clinical affairs, effective immediately. Dr. Williams will provide scientific and technical expertise and leadership across Adverum's clinical development program for ADVM-022, reporting to Julie Clark, M.D., chief medical officer.

    "Jon is a dynamic scientist and prolific published researcher, bringing 25 years of experience in clinical and preclinical drug and medical device development and regulatory strategies to this new position at Adverum," said Julie Clark, M.D., chief medical officer at Adverum Biotechnologies. "His comprehensive knowledge of ocular diseases including angiogenic retinal disease, strategic clinical trial design and execution across all phases of ophthalmic product development will be valuable for our ADVM-022 clinical development program and our pipeline."

    "Ocular gene therapy to treat retinal diseases is an exciting field with the potential to transform the current standard of care for patients," said Dr. Williams. "Adverum is propelling this therapeutic area forward in bold new ways and I am excited to join the company and further its efforts in developing novel therapies."

    Dr. Williams joins Adverum from Bausch Health Companies, where he served as senior director, clinical affairs and was responsible for leading clinical science and medical writing for ophthalmic medical device projects. Previously, he worked at Aerie Pharmaceuticals as director, clinical trial management and medical strategy, and managed clinical protocol development and progress leading to the New Drug Application (NDA) submission for Rhopressa®. Prior to Aerie, Dr. Williams held the positions of director, medical affairs and director, clinical affairs at Bausch + Lomb Incorporated. While there, he was clinical lead for Phase 3 and Phase 4 post-operative steroid treatment programs in adult and pediatric patient populations undergoing cataract surgery. He also served as director of clinical research at ISTA Pharmaceuticals where he led a cross-functional clinical team effort that achieved U.S. regulatory approval of Bepreve® and he wrote Phase 3 multisite clinical protocols and NDA sections for XibromTM and BromdayTM.  Previous to that, he was instrumental in characterizing the novel anti-angiogenic nature of Squalamine, a natural aminosterol product, in several animal models of systemic or ocular disease while executive director for biological research at Magainin Pharmaceuticals.

    Dr. Williams earned a Ph.D. in biophysics from the University of California, San Francisco, and holds a Bachelor of Science in physics, with honors, from Harvey Mudd College. In addition, he completed an N.I.H. Public Health Services post-doctoral fellowship in cancer biology in the Department of Pathology, Stanford University Medical Center.

    On July 1, 2021, the company granted Dr. Williams a stock option to purchase 100,000 shares of Adverum's common stock pursuant to the inducement grant exception under Nasdaq Rule 5635(c)(4), as an inducement that is material to his entering into employment with Adverum. The option has a per share exercise price equal to the closing sales price of Adverum's common stock on the Nasdaq Stock Market on the grant date, and will vest over four years, subject to his continued service with Adverum.

    About Adverum Biotechnologies

    Adverum Biotechnologies (NASDAQ:ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is advancing the clinical development of its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with wet age-related macular degeneration and diabetic macular edema. For more information, please visit www.adverum.com.

    Forward-looking Statements

    Statements contained in this press release regarding the events or results that may occur in the future are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include but are not limited to statements regarding: the role in which Dr. Williams will serve and the benefits that he is expected to bring to Adverum. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. Risks and uncertainties facing Adverum are described more fully in Adverum's Form 10-Q filed with the SEC on May 6, 2021 under the heading "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



    Investor Relations Contacts  
    Amy Figueroa 
    Adverum Biotechnologies, Inc. 
    T: 650-823-2704 
    E: afigueroa@adverum.com  
    
    Media Contact  
    Andrea Cohen  
    Sam Brown Inc.  
    T: 917-209-7163  
    E: andreacohen@sambrown.com

    Primary Logo

    View Full Article Hide Full Article
  5. -- Christopher J. DeRespino appointed acting CFO --

    -- Peter Soparkar appointed COO --

    -- Leone Patterson departs as president and CFO after five years of service --

    REDWOOD CITY, Calif., June 24, 2021 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced that Leone Patterson, president and chief financial officer, has resigned to pursue another opportunity. Christopher J. DeRespino, Adverum's chief business officer, will serve as acting chief financial officer, and Peter Soparkar, chief legal officer, has been appointed chief operating officer. Both appointments are effective immediately, with Mr. DeRespino and Mr…

    -- Christopher J. DeRespino appointed acting CFO --

    -- Peter Soparkar appointed COO --

    -- Leone Patterson departs as president and CFO after five years of service --

    REDWOOD CITY, Calif., June 24, 2021 (GLOBE NEWSWIRE) -- Adverum Biotechnologies, Inc. (NASDAQ:ADVM), a clinical-stage gene therapy company targeting unmet medical needs in ocular and rare diseases, today announced that Leone Patterson, president and chief financial officer, has resigned to pursue another opportunity. Christopher J. DeRespino, Adverum's chief business officer, will serve as acting chief financial officer, and Peter Soparkar, chief legal officer, has been appointed chief operating officer. Both appointments are effective immediately, with Mr. DeRespino and Mr. Soparkar reporting to Laurent Fischer, M.D., Adverum's president and chief executive officer.

    "I would like to thank Leone for her outstanding contributions as a high-impact leader who built a deep bench of talent across the organization over the past five years. She led the company from preclinical to clinical-stage and built our culture as a mission and values-driven organization focused on patients first, which will be her enduring legacy," said Laurent Fischer, M.D., president and chief executive officer at Adverum Biotechnologies. "Chris and Peter are both highly experienced leaders in our industry who are stepping up with expanded responsibilities to lead strong existing teams, exemplifying the future leaders at every level that we foster within Adverum."

    Dr. Fischer continued, "Patient safety remains our top priority for everyone on the Adverum team. As we work with expert advisors on a thorough review of the INFINITY SUSAR patient and data from the ADVM-022 program, we plan to provide an update on the patient, our findings to date, and our future development plans for ADVM-022 as part of our second quarter financial results, planned for August 5, 2021. Gene therapy pushes the boundaries beyond current treatment paradigms and we are grateful for the valuable input from scientific advisors, retina specialists, and investigators as we work to advance this important field of drug development."

    Mr. DeRespino will provide strategic leadership for the company's financial operations and planning, procurement, corporate strategy, and business development. He has more than 15 years of experience in the biopharmaceutical industry and consulting. Prior to joining Adverum as chief business officer, Mr. DeRespino was at Amgen in positions of increasing responsibility, most recently as executive director of business development. Previously, he served as director, asset acquisition/business development at Onyx Pharmaceuticals, which Amgen acquired for $10.4 billion. Mr. DeRespino joined Onyx from Pfizer, where he was director of business development evaluation and strategy and supported numerous transactions across a wide spectrum of therapeutic areas and geographies. Mr. DeRespino earned his MBA from New York University's Leonard N. Stern School of Business and a B.S.E. in biomedical engineering from Johns Hopkins University.

    Mr. Soparkar will lead the company's human resources, legal, information technology, facilities, and select other functions. He has over 15 years of experience, including corporate development, corporate governance, legal, regulatory, commercial, and public compliance activities, for biotechnology companies as well as at a leading international law firm. Previously, Mr. Soparkar was chief legal officer and head of human resources at Counsyl, Inc., where he also served as corporate secretary and head of compliance. Earlier, Mr. Soparkar was at Jazz Pharmaceuticals for 10 years, where he led the legal team's support of company operations and other business matters, including delivering on numerous debt and equity financings and four landmark transactions. Earlier in his career, Mr. Soparkar worked at Latham & Watkins in London and San Francisco, with a practice spanning international and domestic markets, as well as private and public transactions. He received a J.D. from New York University and a B.A. in economics and politics from Oberlin College.

    About Adverum Biotechnologies

    Adverum Biotechnologies (NASDAQ:ADVM) is a clinical-stage gene therapy company targeting unmet medical needs in serious ocular and rare diseases. Adverum is advancing the clinical development of its novel gene therapy candidate, ADVM-022, as a one-time, intravitreal injection for the treatment of patients with wet age-related macular degeneration and diabetic macular edema. For more information, please visit www.adverum.com.

    Forward-looking Statements

    Statements contained in this press release regarding the events or results that may occur in the future are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include but are not limited to statements regarding: the roles in which Mr. DeRespino and Mr. Soparkar will serve and the benefits that they are expected to bring to Adverum, as well as Adverum's plan to provide an update on the INFINITY SUSAR patient, its findings to date, and its future development plans for ADVM-022 as part of its second quarter financial results call, planned for August 5, 2021. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties. Risks and uncertainties facing Adverum are described more fully in Adverum's Form 10-Q filed with the SEC on May 6, 2021 under the heading "Risk Factors." All forward-looking statements contained in this press release speak only as of the date on which they were made. Adverum undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.



    Investor Relations Contacts  
    Amy Figueroa 
    Adverum Biotechnologies, Inc. 
    T: 650-823-2704 
    E: afigueroa@adverum.com  
    
    Media Contact  
    Andrea Cohen  
    Sam Brown Inc.  
    T: 917-209-7163  
    E: andreacohen@sambrown.com  

    Primary Logo

    View Full Article Hide Full Article
View All Adverum Biotechnologies Inc. News